LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455

{0}------------------------------------------------ # Summary of Safety and Effectiveness Liquichek Qualitative Urine Toxicology Control #### 1.0 Submitter Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax: ## Contact Person Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367 # Date of Summary Preparation October 14, 2003 ### Device Identification 2.0 Liquichek Qualitative Urine Toxicology Control Product Trade Name: Drug Mixture Control Common Name: Class I Classifications: DIF Product Code: 21 CFR 862.3280 Requlation Number: ### Device to Which Substantial Equivalence is Claimed 3.0 Liguichek Qualitative Urine Toxicology Control Bio-Rad Laboratories Irvine, California Docket Number: K001973 #### Description of Device 4.0 Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers, and constituents of animal origin. The control is provided in liquid form for convenience. #### 5.0 Statement of Intended Use Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology. {1}------------------------------------------------ ### Comparison of the new device with the Predicate Device 6.0 The new Liquichek Qualitative Urine Toxicology Control contains 3,4-Methylenedioxymethamphetamine (MDMA), and the currently marketed Liquichek Qualitative Urine Toxicology Control (K001973) to which substantial equivalence is claimed does not contain MDMA. | | Bio-Rad Liquichek Qualitative<br>Urine Toxicology Control<br>(New Device) | Bio-Rad Liquichek Qualitative<br>Urine Toxicology Control<br>(Predicate Device K001973) | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | | | | | Similarities | | | Intended Use | Liquichek Qualitative Urine Toxicology Control is<br>intended for use as an assayed quality control urine to<br>monitor the performance of laboratory procedures for<br>qualitative urine toxicology. | Liquichek Qualitative Urine Toxicology Control is<br>intended for use as an assayed quality control urine<br>to monitor the performance of laboratory procedures<br>for qualitative urine toxicology. | | Form | Liquid | Liquid | | Matrix | Urine | Urine | | Storage<br>(Unopened) | 2-8°C until expiration date | 2-8°C until expiration date | | Open Vial | 30 days at 2 to 8°C or 18 to 25°C | 30 days at 2 to 8°C or 18 to 25°C | | | Differences | | | Drugs | Same as the predicate device with the addition of:<br>3,4-Methylenedioxymethamphetamine (MDMA), | 11-Nor-Δ-9-THC-9-COOH, Amphetamines,<br>Barbiturates, Benzodiazepines, Benzoylecgonine,<br>Cannabinoids, Cocaine, d-Amphetamine, d-<br>Methamphetamine, Ethanol, Lysergic Acid<br>Diethylamide (LSD), Methadone, Methaqualone,<br>Morphine, Free; Nordiazepam, Nortriptyline,<br>Opiates, Oxazepam, Phencyclidine, Propoxyphene,<br>Secobarbital, Tricyclic Antidepressants (TCA)<br>Does not contain:<br>3,4-Methylenedioxymethamphetamine (MDMA) | | Label Warnings | Does not require hazard symbols | Requires hazard symbols | Table 1. Similarities and Differences between new and predicate device. # 2.0 STATEMENT OF SUPPORTING DATA Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control. Product claims are as follows: - 2.1 Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8ºC or 18 to 25°C. - 2.2 Shelf Life: 3 Years at 2 to 8°C - 2.3 Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three wavy lines that converge at the bottom, representing the flow of health and human services. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 2 2003 Ms. Maria Zeballos, RAC Regulatory Affairs Specialist Bio-Rad Laboratories, QSD Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017 k033366 Re: Trade/Device Name: Liquichek Qualitative Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 14, 2003 Received: October 21, 2003 Dear Ms. Zeballos: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Butman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510 (k) Number (if known): k033366 Device Name: Liquichek Qualitative Urine Toxicology Control Indications for Use: Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology. (PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use ***_***_ or Over-the Counter use ***_***_ Albuth Suin **Division Sign-Off** for Jean Cooper Office of In Vitro Diagnostic Device Evaluation and Safety 210(k)